US Representation:
We provide the US drug listing and US agent services to enable our clients for easy access to US FDA through us.
US agent and drug listing Services:
- US agent services
- We interact with FDA for the all the submission
- Support in compilation and writing of the submission for US FDA and its life cycle management.
- We perform eCTD publishing and its Submission to the US FDA for all the submission like IND, NDA, BLA, ANDA, DMF’s
- US Drug Listing services
- Establishment registration (ER)
- Labelor code Application
- NDC (national drug code) and Drug listing
- Annual update for ER
- Annual Listing Certification for eDRLS
- GDUFA cover Sheet filing
- Self-Identification
Indian Representation:
NUVO Consultancy, your Indian agent and regulatory partner helps you to get through all the regulatory application and approvals, but not limited to Drugs, Cosmetic and medical devices with CDSCO and DCGI office.
We at NUVO, provide full support for all the Drugs, Cosmetics, Medical devices & Biologics
- New Drug Approvals
- FDC Approvals
- Import & Registration
- Global Clinical Trials
- BA/BE NOC
- Post Approvals
- Medical Devices
- Cosmetics Import Registration
- Embassy Attestation
- Nutraceuticals/Food Supplements Approval – FSSAI
- Ethics Committee Registration
- Vaccines & Biological Products
We can act as your authorized Indian agent and representative, and will get sorted all the licensing, filings and approvals needs for easy penetration in to Indian market.
We are with you throughout the approval process from new drugs to generics:
- Suggestions of new drug molecules
- Analysing approval requirements
- Coordinate & compile dossier
- Help connect to trusted BE Centres/CROs
- Pre-screening technical documents for errors
- Performing submissions (online & offline)
- Assistance in query replies
- Physical follow-ups at Govt. Departments.
- All-round assistance for SEC Presentations
- On-time Approval
Others Countries are also supported, please contact us for further information.
